川丹双叶滴丸的制备及质量标准的研究
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摘要
心脑血管疾病是人类健康的“第一杀手”,所谓心脑血管疾病主要指冠心病、心绞痛和高血压等。此病不但会影响病人的生活并给病人及其家属、社会带来极大危害,还是造成心、脑、肾等重要器官损害的罪魁祸首。随着社会发展和人民群众生活水平的提高,冠心病在中老年人群中的发病率呈逐年上升趋势,心绞痛、心肌梗死的发作又严重威胁着这类患者的生命安全。
近年来,随着中药剂型的不断发展,滴丸在中药剂型的应用也越来越引人注目,由于该剂型具有能够提高某些难溶性药物的生物利用度,操作方便,工序少,周期短等突出优点,川丹双叶滴丸可以成为优于片剂的一种新中药剂型,因此我们对治疗胸痹心痛(冠心病、心绞痛、中风)的复方中药制剂川丹双叶滴丸的研制进行了较为系统的探讨。
确定丹参的提取工艺为：取丹参药材粉碎成粗粉,加10倍量95%乙醇回流提取1次3h,滤过,合并滤液,滤液浓缩干燥,得浸膏。醇提后药渣加水10倍量水煎煮2次,每次90min,合并滤液,滤液浓缩干燥,采用冻干干燥,得干粉。
川芎提取为：取川芎药材粉碎成粗粉,加12倍量80%乙醇浸泡1.5小时,回流提取3次,每次2 h,滤过,合并滤液,滤液浓缩干燥,得浸膏。
银杏叶提取物的制备工艺为：粉碎的银杏叶以50%乙醇回流提取2次,50%乙醇用量分别为8倍量、6倍量,回流时间分别为2 h、1 h,合并回流提取液,减压浓缩至1：1.5,加乙醇至含醇75%,取上清液减压浓缩至1：4,再加乙醇至80%,冷沉48 h后,取上清液调pH8.8-9.0,离心过滤。滤液减压浓缩回收乙醇,用水稀释至6倍后用HCl调节pH6.8～7.0。取等量D-101树脂和聚酰胺树脂装柱,将银杏叶提取物水溶液通过混合柱,以10倍量水洗后,70%乙醇解吸,洗脱液浓缩,干燥得成品。
山楂叶的制备工艺为：粉碎的山楂叶60%乙醇回流提取3次,每次2小时。滤过,合并滤液,滤液浓缩干燥,得浸膏。
采用正交设计优选了滴丸成型工艺,确定工艺为：取丹参、川芎、银杏叶、山楂叶提取物混合,按1：3比例加入到熔融的基质中(PEG4000与PEG6000的比例为1：1)混合均匀,85℃保温下倒入滴丸机中,以滴距5 cm滴入液体石蜡冷凝剂中,冷却,固化成丸。
采用薄层色谱法对制剂中药物银杏叶提取物、丹参、山楂叶、川芎进行了定性鉴别,采用高效液相色谱法对丹参中的主要有效成分丹参酮ⅡA、川芎中的主要有效成分阿魏酸进行了含量测定及方法学考察,制定了质量标准。考察了制剂的初步稳定性,结果表明,制剂稳定性良好。
Angiocardiopathy and cerebrovascular disease is the first killer of heathy for mamkind. They mainly contain coronary heart disease, apoplexy, hypertension and so on. The diseases not only influence the life of patients and bring harmfulness to patients,their family and society but also damage some important organa containing heart, brain, kidney as well.With the development of society and people's living standards, the incidence of coronary heart disease in the elderly population have increased year by year and the onset of angina pectoris, myocardial infarction have serious threat to these patients lives.
Recently,with the development of dosage form of Chinese drugs,dropping pills have attracted more and more attention.The preparation formulation can improve the bioavailability of some insoluble drugs and have the merits of convenient operating,less procedure,short periodicity and so on.lt is believed that droping pill of Chuan Dan Shuang Ye is the ideal dosage form prior to the tablet of it.Thus we have systematically developed the process of preparation of Chuan Dan Shuang Ye dropping pill which treat coronary heart disease, heartstroke and apoplexy.
The process of extracting and refinery is that crude drugs of salvia miltiorrhiza are pulverised into coarse powder, and be decocted three times with 10 times as much 95% ethanol as the weight of raw drugs for three hours one time, then are filtrated. The filtrate is combined and concentrated into the sample solution. After alcohol extraction, decocting two times with 10 times as much water as the weight of the dregs for 90min every time, then are filtrated. The filtrate is combined and concentrated drying into extract.
The preparation process of Rhizoma Chuanxiong is as followed:crude drugs of Rhizoma Chuanxiong are pulverised into coarse powder, and be decocted three times with 12 times as much 80% ethanol as the weight of raw drugs for one and a half hours every time, then are filtrated. The filtrate is combined and concentrated into the sample solution.
Extract of Ginkgo biloba leaves (EGb) is gained according to the procedure below. The pulverised Ginkgo biloba leaves are firstly extracted under reflux with 8 times as much 50% ethanol as the weight of crude drugs for two hour,is secondly extracted under reflux with 6 times as much 50% ethanol as the weight of crude drugs for an hour.The extracting solution is combined and concentrated to 1:1.5,is added ethanol to the solution containing 75% ethanol.The supernate is decompressed and concentrated to 1:4,is added ethanol to the solution containing 80% ethanol again.After stewing for 48 hour,the pH of supernate is adjusted to 8.8～9.0 and it was centrifugally filtrated and decompressed and concentrated to the solution containing no ethanol.Then it was dissolved to 6 times and adjusted pH to 6.8-7.0 with hydrochloric acid. Place equivalent D-101 resin and polyamide resin in the column.The extration solution of Gingko leaves is passed through the column.Firstly elute the column with 10 times as much water as the volume of the resin column in order to remove the soluble impurity,secondly with 10 times as much 70% ethanol as the volume of the resin column.Collect the ethanol eluent and concentrate it. The finish product is gained.
The preparation process of Chinese hawthorn leaves is as followed:crude drugs of Chinese hawthorn leaves are pulverised into coarse powder, and be decocted three times with 8 times as much 60% ethanol as the weight of raw drugs for two hours every time, then are filtrated.The filtrate is combined and concentrated into the sample solution.The finish product of Chinese hawthorn leaves sample is gained.
Using orthogonal desin we have optimized the preparation process of Chuan Dan Shuang Ye dropping pill that the mixture of extraction is placed into fused host containing equivalent PEG4000 and PEG6000 at the ratio of 1:3,mixed and decanted into dropping pill machine at 85℃,then is dropped into fluid wax at the dropping distance of 5 cm. Cool and solidify into pills.
Salvia miltiorrhiza,the extraction of Gingko biloba leaves,Chinese hawthorn leaves and Rhizoma Chuanxiong are qualitatively identified by thin-layer chromatography.High efficiency performance liquid chromatography is applied to quantitative analysis and methodological evaluation of salviolⅡA in Salvia miltiorrhiza and ferulaic acid in Rhizoma Chuanxiong. According to it the quality standard is made.The stability measurement have suggested the dropping pills has good stability.
近年来,随着中药剂型的不断发展,滴丸在中药剂型的应用也越来越引人注目,由于该剂型具有能够提高某些难溶性药物的生物利用度,操作方便,工序少,周期短等突出优点,川丹双叶滴丸可以成为优于片剂的一种新中药剂型,因此我们对治疗胸痹心痛(冠心病、心绞痛、中风)的复方中药制剂川丹双叶滴丸的研制进行了较为系统的探讨。
确定丹参的提取工艺为：取丹参药材粉碎成粗粉,加10倍量95%乙醇回流提取1次3h,滤过,合并滤液,滤液浓缩干燥,得浸膏。醇提后药渣加水10倍量水煎煮2次,每次90min,合并滤液,滤液浓缩干燥,采用冻干干燥,得干粉。
川芎提取为：取川芎药材粉碎成粗粉,加12倍量80%乙醇浸泡1.5小时,回流提取3次,每次2 h,滤过,合并滤液,滤液浓缩干燥,得浸膏。
银杏叶提取物的制备工艺为：粉碎的银杏叶以50%乙醇回流提取2次,50%乙醇用量分别为8倍量、6倍量,回流时间分别为2 h、1 h,合并回流提取液,减压浓缩至1：1.5,加乙醇至含醇75%,取上清液减压浓缩至1：4,再加乙醇至80%,冷沉48 h后,取上清液调pH8.8-9.0,离心过滤。滤液减压浓缩回收乙醇,用水稀释至6倍后用HCl调节pH6.8～7.0。取等量D-101树脂和聚酰胺树脂装柱,将银杏叶提取物水溶液通过混合柱,以10倍量水洗后,70%乙醇解吸,洗脱液浓缩,干燥得成品。
山楂叶的制备工艺为：粉碎的山楂叶60%乙醇回流提取3次,每次2小时。滤过,合并滤液,滤液浓缩干燥,得浸膏。
采用正交设计优选了滴丸成型工艺,确定工艺为：取丹参、川芎、银杏叶、山楂叶提取物混合,按1：3比例加入到熔融的基质中(PEG4000与PEG6000的比例为1：1)混合均匀,85℃保温下倒入滴丸机中,以滴距5 cm滴入液体石蜡冷凝剂中,冷却,固化成丸。
采用薄层色谱法对制剂中药物银杏叶提取物、丹参、山楂叶、川芎进行了定性鉴别,采用高效液相色谱法对丹参中的主要有效成分丹参酮ⅡA、川芎中的主要有效成分阿魏酸进行了含量测定及方法学考察,制定了质量标准。考察了制剂的初步稳定性,结果表明,制剂稳定性良好。
Angiocardiopathy and cerebrovascular disease is the first killer of heathy for mamkind. They mainly contain coronary heart disease, apoplexy, hypertension and so on. The diseases not only influence the life of patients and bring harmfulness to patients,their family and society but also damage some important organa containing heart, brain, kidney as well.With the development of society and people's living standards, the incidence of coronary heart disease in the elderly population have increased year by year and the onset of angina pectoris, myocardial infarction have serious threat to these patients lives.
Recently,with the development of dosage form of Chinese drugs,dropping pills have attracted more and more attention.The preparation formulation can improve the bioavailability of some insoluble drugs and have the merits of convenient operating,less procedure,short periodicity and so on.lt is believed that droping pill of Chuan Dan Shuang Ye is the ideal dosage form prior to the tablet of it.Thus we have systematically developed the process of preparation of Chuan Dan Shuang Ye dropping pill which treat coronary heart disease, heartstroke and apoplexy.
The process of extracting and refinery is that crude drugs of salvia miltiorrhiza are pulverised into coarse powder, and be decocted three times with 10 times as much 95% ethanol as the weight of raw drugs for three hours one time, then are filtrated. The filtrate is combined and concentrated into the sample solution. After alcohol extraction, decocting two times with 10 times as much water as the weight of the dregs for 90min every time, then are filtrated. The filtrate is combined and concentrated drying into extract.
The preparation process of Rhizoma Chuanxiong is as followed:crude drugs of Rhizoma Chuanxiong are pulverised into coarse powder, and be decocted three times with 12 times as much 80% ethanol as the weight of raw drugs for one and a half hours every time, then are filtrated. The filtrate is combined and concentrated into the sample solution.
Extract of Ginkgo biloba leaves (EGb) is gained according to the procedure below. The pulverised Ginkgo biloba leaves are firstly extracted under reflux with 8 times as much 50% ethanol as the weight of crude drugs for two hour,is secondly extracted under reflux with 6 times as much 50% ethanol as the weight of crude drugs for an hour.The extracting solution is combined and concentrated to 1:1.5,is added ethanol to the solution containing 75% ethanol.The supernate is decompressed and concentrated to 1:4,is added ethanol to the solution containing 80% ethanol again.After stewing for 48 hour,the pH of supernate is adjusted to 8.8～9.0 and it was centrifugally filtrated and decompressed and concentrated to the solution containing no ethanol.Then it was dissolved to 6 times and adjusted pH to 6.8-7.0 with hydrochloric acid. Place equivalent D-101 resin and polyamide resin in the column.The extration solution of Gingko leaves is passed through the column.Firstly elute the column with 10 times as much water as the volume of the resin column in order to remove the soluble impurity,secondly with 10 times as much 70% ethanol as the volume of the resin column.Collect the ethanol eluent and concentrate it. The finish product is gained.
The preparation process of Chinese hawthorn leaves is as followed:crude drugs of Chinese hawthorn leaves are pulverised into coarse powder, and be decocted three times with 8 times as much 60% ethanol as the weight of raw drugs for two hours every time, then are filtrated.The filtrate is combined and concentrated into the sample solution.The finish product of Chinese hawthorn leaves sample is gained.
Using orthogonal desin we have optimized the preparation process of Chuan Dan Shuang Ye dropping pill that the mixture of extraction is placed into fused host containing equivalent PEG4000 and PEG6000 at the ratio of 1:3,mixed and decanted into dropping pill machine at 85℃,then is dropped into fluid wax at the dropping distance of 5 cm. Cool and solidify into pills.
Salvia miltiorrhiza,the extraction of Gingko biloba leaves,Chinese hawthorn leaves and Rhizoma Chuanxiong are qualitatively identified by thin-layer chromatography.High efficiency performance liquid chromatography is applied to quantitative analysis and methodological evaluation of salviolⅡA in Salvia miltiorrhiza and ferulaic acid in Rhizoma Chuanxiong. According to it the quality standard is made.The stability measurement have suggested the dropping pills has good stability.
引文
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